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U.S. Department of Health and Human Services

Recognized Consensus Standards

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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 051 Date of Entry 01/14/2019 
FR Recognition Number 12-322
NEMA MS 5-2018 Determination of Slice Thickness in Diagnostic Magnetic Resonance Imaging
Scope/Abstract
This standards publication provides a method for determining the slice thickness of proton images. Both the typical and the typically thinnest slices in routine clinical use for a particular system are determined at one location within the specification volume and only one of the three orthogonal orientations (transverse, sagittal, or coronal). Imaging types and conditions not addressed by this standard include spectroscopy, chemical shift imaging, and warped slices.
Extent of Recognition
Complete standard
Rationale for Recognition
This standard is relevant to medical devices and is recognized on its scientific and technical merit and/or because it supports existing regulatory policies.
Transition Period
FDA recognition of NEMA MS 5-2011 [Rec# 12-231] will be superseded by recognition of NEMA MS 5-2018 [Rec# 12-322]. FDA will accept declarations of conformity, in support of premarket submissions, to [Rec # 12-231] until December 28, 2019. After this transition period, declarations of conformity to [Rec # 12-231] will not be accepted.
Public Law, CFR Citation(s) and Procode(s)*
Regulation Number Device Name Device Class Product Code
§892.1000 Coil, Magnetic Resonance, Specialty Class 2 MOS
§892.1000 Mri Disposable Kit Class 2 OIM
§892.1000 System, Nuclear Magnetic Resonance Imaging Class 2 LNH
§892.1000 System, Nuclear Magnetic Resonance Spectroscopic Class 2 LNI
Relevant FDA Guidance and/or Supportive Publications*
Guidance for Industry and Food and Drug Administration Staff: Submission of Premarket Notifications for Magnetic Resonance Diagnostic Devices, Issued November 18, 2016

Guidance for Industry and Food and Drug Administration Staff: Criteria for Significant Risk Investigations of Magnetic Resonance Diagnostic Devices, Issued June 20. 2014

FDA Technical Contact
 Ting Song
  FDA/OC/CDRH/OPEQ/OHTVI/DHTVIA/
  301-796-7677
  ting.song@fda.hhs.gov
Standards Development Organization
NEMA National Electrical Manufacturers Association https://www.nema.org/
FDA Specialty Task Group (STG)
Radiology
*These are provided as examples and others may be applicable.
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